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FAQs about Acromegaly &
IGF-I Levels

Q: What is acromegaly?

A: Acromegaly is a rare disease that occurs when the body makes too much growth hormone and IGF-I. This leads to the body tissues and organs growing too much. Acromegaly can also increase a person’s risk of having dangerous complications such as cardiovascular disease, diabetes, hypertension, sleep apnea, arthritis, and osteoporosis.

Q: What symptoms can acromegaly cause?

A: There are many pains and problems caused by acromegaly. These may include:

Pain in the joints (like knees or hips)
Headaches
Fatigue (weakness)
Sweating more than normal
Swelling in the hands or feet
Increased ring size

Acromegaly has many more symptoms than the ones listed above. Talk with your doctor for more details.

Q: What other problems are commonly seen with acromegaly?

A: Your doctor will also ask you about other problems you may be having that often occur with acromegaly. These may include:

Cardiovascular disease
Diabetes
Hypertension
Sleep apnea
Arthritis
Osteoporosis

Q: What causes acromegaly?

A: Most of the time, acromegaly is caused by a benign tumor in the pituitary gland. The pituitary gland is a tiny organ in the brain. It helps your body with normal functions like growth in childhood, healthy bones and muscles. A tumor can cause the pituitary gland to produce too much growth hormone (GH). When there is too much GH in your body, it triggers the body to make too much insulin-like growth factor I (IGF-I).

Q: What is IGF-I?

A: IGF-I (insulin-like growth factor-I) is a hormone made by your body. In acromegaly, your body makes too much IGF-I. This causes organs and tissues to grow too much.

Q: Why are IGF-I levels important in acromegaly?

A: It’s important to keep your IGF-I levels within the normal range for people your age because:

It suggests that your acromegaly is under control; and
It helps to improve the signs and symptoms of acromegaly.

Q: How will I know if I have acromegaly?

A: To find out if you have acromegaly, a doctor will run blood tests to measure your levels of GH and IGF-I. If these levels are too high, you may need a scan called an MRI. The MRI can help find and measure the tumor that is causing too much GH and IGF-I in your body.

Q: How is acromegaly treated?

A: Treating acromegaly may require surgery, radiation therapy, and/or medicine. For most people, the first treatment for acromegaly is surgery to remove as much of the tumor as possible. Many people also need prescription medicines to help control their hormone levels, including IGF-I levels.

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SOMAVERT (pegvisomant for injection) is a prescription medicine for acromegaly. It is for patients whose disease has not been controlled by surgery, radiation, and/or other medical therapies, or patients for whom these options are not appropriate. The goal of treatment with SOMAVERT is to have a normal IGF-I level in the blood.

Important Safety Information for Patients

Do not use SOMAVERT if you are allergic to SOMAVERT or anything that is in it.

Be sure to tell your doctor if you use narcotic painkillers (opioid medicines) because the dose of SOMAVERT may need to be changed.

Tumors that make growth hormone may grow in people with acromegaly. Studies have shown that the size of these tumors generally does not change for people who use SOMAVERT. Even so, these tumors need to be watched carefully by your doctor. Your doctor may ask you to have a magnetic resonance imaging (MRI) test to monitor the size of your tumor.

Blood sugar levels may go down when taking SOMAVERT. Be sure to tell your doctor if you use insulin or other medicines (oral hypoglycemic medicines) for diabetes. The dose of these medicines may need to be reduced when you use SOMAVERT.

Some people who have used SOMAVERT have developed liver problems. These problems generally disappeared when those people stopped taking SOMAVERT.

Stop the drug right away and call your doctor if you get any of these symptoms:

Your skin or the white part of your eyes turns yellow (jaundice)
Your urine turns dark
Your bowel movements (stools) turn light in color
You do not feel like eating for several days
You feel sick to your stomach (nausea)
You have unexplained tiredness
You have pain in the stomach area (abdomen)

Your doctor may do blood tests before and during your treatment with SOMAVERT to check that the IGF-I levels in your blood are normal and/or that your liver is working correctly. Your dose of SOMAVERT may be changed based on the results of these tests.

The most common side effects with SOMAVERT are pain, infection, reaction at the injection site, flu-like symptoms, nausea, and diarrhea. These are not all of the possible side effects of SOMAVERT. For more information, speak to your doctor.

Inject SOMAVERT in a different place on your body each day. This can help prevent skin problems such as lumpiness or soreness.

SOMAVERT has not been studied in pregnant women. It is not known if SOMAVERT passes into the mother’s milk or if it can harm the baby.

You are encouraged to report negative side effects of prescription drugs to the FDA. Visit www.fda.gov/medwatch or call 1-800-FDA-1088.

The health information contained herein is provided for educational purposes only and is not intended to replace discussions with a healthcare provider. All decisions regarding patient care must be made with a healthcare provider, considering the unique characteristics of the patient.

This product information is intended only for residents of the United States and Puerto Rico. The products discussed herein may have different labeling in different countries.

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FAQs about Acromegaly & IGF-I Levels